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Moving Toward Evidence-Based Human Participant Protection

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Abstract

There is near universal recognition that human participant protection is both morally and practically essential for all forms of research involving humans. Yet most of the discourse around human participant protection has focussed on norms—rules, regulations and governance arrangements—rather than on the actual effectiveness of these norms in achieving their ends—protecting participants from undue risk and ensuring respectful treatment as well as advancing the generation of useful knowledge. In recent years there has been increasing advocacy for evidence-based human participant protection that would be grounded on the careful investigation of the effects of research on human participants. We offer an analysis of evidence-based protection and then focus on Canadian examples of research on evidence-based protection. We consider the prospects for such research being put into practice in Canada. Finally we connect our remarks to the theme of “the changing landscape of human participant protection.”

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Notes

  1. Personal communication from Roberta Woodgate regarding a paper presented at the 19th Annual Canadian Bioethics Society Conference 2008 in St. John’s Newfoundland.

  2. Darquise Lafrenière (Postdoctoral Fellow, CIHR Ethics of Health Research and Policy Training Program) and Susan Cox are piloting the use and assessment of arts-based methods as a novel method of knowledge translation. This work was recently presented in poster format at the 2008 PRIM&R meetings in Orlando, Florida.

  3. Lyrics taken from http://www.absolutelyrics.com/lyrics/view/madeleine_peyroux/weary_blues/

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Acknowledgments

The authors wish to acknowledge the Canadian Institution of Health Research (CIHR) for providing grant funding for both the Centring the Human Subject in Health Research project and the Canadian Network for the Governance of Ethical Health Research Involving Humans. We would also like to acknowledge Kim Taylor for her assistance in preparing this manuscript.

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Authors and Affiliations

  1. Maurice Young Centre for Applied Ethics, University of British Columbia, Vancouver, BC, Canada

    Michael McDonald & Susan Cox

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  1. Michael McDonald
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  2. Susan Cox
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Correspondence to Michael McDonald.

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McDonald, M., Cox, S. Moving Toward Evidence-Based Human Participant Protection. J Acad Ethics 7, 1–16 (2009). https://doi.org/10.1007/s10805-009-9082-3

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